Cleared Traditional

H.V. PULSE LAVAGE (L31 SERIES) (K970916) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970916 · Global Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
100d
Days
Class 2
Risk

K970916 is an FDA 510(k) clearance for the H.V. PULSE LAVAGE (L31 SERIES). Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Global Medical Products, Inc. (Las Vegas, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 100 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5475 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Global Medical Products, Inc. devices

Submission Details

510(k) Number K970916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1997
Decision Date June 20, 1997
Days to Decision 100 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FQH Lavage, Jet

All 18
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K970916.
The VersaJet II Hydrosurgery System
K143115 · Smith & Nephew, Inc. · Jul 2015
VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH
K110958 · Smith & Nephew, Inc. · Aug 2011
ARTISAN PULSE LAVAGE SYSTEM
K972551 · Howmedica Corp. · Oct 1997
DAVOL SURGICAL SUCTION IRRIGATION INSTR
K830386 · C.R. Bard, Inc. · Mar 1983
EXETER BONE LAUAGE SYSTEM
K790811 · Howmedica Corp. · Jul 1979